Annals of Epidemiology
Volume 19, Issue 7 , Pages 494-500, July 2009

Analysis of the Quality of Reporting of Randomized Controlled Trials in Acute and Chronic Myeloid Leukemia, and Myelodysplastic Syndromes as Governed by the CONSORT Statement

  • Dimitrios C. Ziogas

      Affiliations

    • Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece
    • ,
  • Elias Zintzaras

      Affiliations

    • Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece
    • Center for Clinical Evidence Synthesis, The Institute for Clinical Research and Health Policy Studies, Tufts–New England Medical Center, Tufts University School of Medicine, Boston, MA
    • Corresponding Author InformationAddress correspondence to: Elias Zintzaras, Head, Department of Biomathematics, University of Thessaly School of Medicine, Papauyriazi 22, Larissa 41222, Greece. Tel/Fax: +30-2410-56506.

Received 1 August 2008; accepted 17 March 2009.

Purpose

Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement is an evidence-based approach to improve the quality of RCTs. The aim of this study was to evaluate the reporting quality of published RCTs concerning myeloid hematologic malignancies according to the CONSORT statement.

Methods

PubMed was searched for English-language RCTs involving patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML) and myelodysplastic syndromes (MDS). Trials were considered eligible when participants were randomly assigned to at least two treatment arms and included patients with AML, CML or MDS. Quality of reporting was assessed using a 24–item questionnaire based on the CONSORT checklist. Reporting was assessed in one pre-CONSORT (1988–1995) and one post–CONSORT (1996–2008) period. The effect of CONSORT statement in high- and low-ranked journals, according to their impact factor, has also been evaluated.

Results

The search identified 261 eligible articles for analysis. Only 13 of the 24 items of CONSORT statement were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Significant improvements over time were seen for items that assessed the methodological quality, while RCTs published in high-ranked journals showed better quality of reporting.

Conclusions

Quality of reporting in RCTs focusing on myeloid malignancies remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.

Key Words: CONSORT, Randomized Controlled Trials, Quality, Myeloid Leukemia, Hematologic Malignancy, Myelodysplastic Syndromes, Methodology

Selected Abbreviations and Acronyms: RCT, randomized controlled trial, CONSORT, Consolidated Standards of Reporting Trials, ITT, intention-to-treat, AML, acute myeloid leukemia, CML, chronic myeloid leukemia, MDS, myelodysplastic syndromes, IF, impact factor

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PII: S1047-2797(09)00107-0

doi:10.1016/j.annepidem.2009.03.018

Annals of Epidemiology
Volume 19, Issue 7 , Pages 494-500, July 2009

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